RESEARCH ON RESEARCH INTEGRITY
Release Date: May 7, 2001
RFA: RFA-NS-02-005
Office of Research Integrity
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
Letter of Intent Receipt Date: October 15, 2001
Application Receipt Date: November 19, 2001
THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS
THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.
PURPOSE
The Office of Research Integrity (ORI, DHHS), the National Institute of
Neurological Disorders and Stroke (NINDS, NIH) and the National
Institute of Nursing Research (NINR, NIH) invite applications to
support research on research integrity. "Integrity” in this context is
understood as “adherence to rules, regulations, guidelines, and
commonly accepted professional codes or norms.”
Research integrity is a vital component both of the reliability of the
research record and of the trust that underlies public support for
research. Therefore the responsible expenditure of public funds for
research must include attention to research integrity. The purpose of
the proposed grant program is to foster empirical research on the
institutions, processes, and values that affect integrity in research.
The sponsoring agencies are particularly interested in studies that
will inform policy making at DHHS, NIH, and research institutions, with
the goal of fostering appropriate attention to integrity in publicly
funded research programs.
RESEARCH OBJECTIVES
Background
In the early 1980s, research integrity became a major national concern
as a consequence of a number of well-publicized cases of research
misconduct. Since that time, thousands of publications have in one way
or another reported on, analyzed, and/or expressed opinions about
integrity in publicly funded research. However, only limited attention
has been directed toward research on research integrity. Little is
known about the causes and significance of or remedies for practices
that fall short of professional standards for conducting research.
There is not enough empirical evidence to determine whether intentional
misconduct in research is rare or widespread. The impact of compromises
in integrity on the public and on the research record has not been
assessed. No systematic effort has been made to evaluate different
approaches to transmitting high standards for integrity in research,
making it difficult to know which ones, if any, are effective.
The lack of research on research integrity presents a significant
problem for government, research institutions, researchers and their
professional societies. If integrity is defined as being truthful and
living up to professional standards that researchers and research
institutions set for themselves, there is ample evidence to suggest
that publicly funded research can fall short of this standard. Some
researchers have engaged in practices that clearly constitute research
misconduct. Research results can be inappropriately influenced by
bias, conflicts of interest, and carelessness, and personal ambitions
can obscure the objectivity of the research process. However, the lack
of generalizable empirical evidence relating to research integrity
makes it difficult to develop rational policies for these problems or
to assess the potential harm to the public health caused when standards
for good practice are compromised.
Areas of interest
This RFA seeks to address the need for more and better information on
the factors that encourage and/or discourage integrity in publicly
funded research. For the purposes of this RFA, “research” is defined
broadly to include societal, institutional and individual aspects of
the enterprise. “Integrity” is understood as “adherence to rules,
regulations, guidelines, and commonly accepted professional codes or
norms.” Proposals are encouraged that will provide generalizable
empirical knowledge about the ways in which researchers and research
institutions meet or fail to meet their professional responsibilities
in the conduct, evaluation, and reporting of research. Particular
areas of interest include but are not limited to:
o Research norms and/or practices, such as: How do researchers make
decisions about what they should and should not do as professionals?
Do workplace conditions and career pressures affect their decisions?
What responsibilities do they accept or reject and why? How do they
learn about these responsibilities? How do they define and deal with
conflicting responsibilities?
o Institutional climate and responsibility, such as: What
responsibilities do research institutions and scientific societies
accept for maintaining the integrity of their research programs? How
do they meet these responsibilities? Do research institutions or
professional societies promote values that effectively encourage high
standards for integrity? What impact does institutional climate have
on the attitudes and practices of individual researchers?
o Education on the responsible conduct of research (RCR), such as:
What impact, if any, does RCR education have on research integrity?
Are some approaches (i.e., mentoring, case study, class-room lectures)
to RCR education more effective than others? What methods or
instruments are best suited for assessing the effectiveness of RCR
education?
o Mentor/trainee relationships, such as: What are the
responsibilities of mentors and trainees in pre-doctoral and post-
doctoral research programs (i.e., role or responsibilities of a mentor,
conflicts between mentor and trainee, collaboration and competition,
selection of a mentor, and abusing the mentor/trainee relationship)?
o Data acquisition, management, sharing, and ownership. What are the
accepted practices for acquiring and maintaining research data? What
are the proper methods for record keeping and electronic data
collection and storage in scientific research (i.e., defining what
constitutes data; keeping data notebooks or electronic files; data
privacy and confidentiality; data selection, retention, sharing,
ownership, and analysis; data as legal documents and intellectual
property, including copyright laws)?
o Responsible authorship, such as: What is the level of accountability
among authors? How pervasive are problems associated with
collaborative work and assigning appropriate credit, acknowledgments,
appropriate citations, repetitive publications, fragmentary
publication, sufficient description of methods, corrections and
retractions, conventions for deciding upon authors, author
responsibilities, and the pressure to publish?
o Integrity of publication practices and the research record, such as:
Are research results quickly, fairly, and accurately disseminated? Is
research effectively self-correcting? How effective are different
approaches (e.g., peer review, data audits, or detailed research and
publication guidelines) to encouraging and ensuring the integrity of
the research record?
o Research collaborations and issues that may arise from such
collaborations, such as: setting ground rules early in the
collaboration, avoiding authorship disputes, and the sharing of
materials and information with internal and external collaborating
scientists.
o Conflict of interest, such as: How do conflicting interests impact
the conduct and results of research? How do individuals, research
institutions, and professional societies recognize and manage conflicts
of interest? Are financial conflicts of interest a growing concern in
research, and if so, what impact do they have? Are existing conflict
of interest policies known and effective?
o The meaning of research misconduct and the regulations, policies, and
guidelines that govern research misconduct in PHS-funded institutions,
such as: How pervasive is fabrication, falsification, and plagiarism;
error vs. intentional misconduct? How effective are institutional
misconduct policies? How effective are institutional structures in
identifying misconduct? How effective are the procedures for reporting
misconduct; protection of whistleblowers; and outcomes of
investigations, including institutional and Federal actions.
Relevant research perspectives and disciplines include, but are not
limited to: anthropology, applied philosophy, business, economics,
education, information studies, law, organizational studies, political
science, psychology, sociology, and survey and evaluation research,
plus the physical, biomedical, and clinical sciences, including
nursing. The NINR is particularly interested in research done by
nurses on these topics.
SPECIAL REQUIREMENTS
Successful applicants will be asked to participate in future ORI-
sponsored conferences on research on research integrity to report
progress, discuss problems, and share information related to the
conduct of their grants. It is recommended that costs associated with
attendance of the principal investigator at one meeting per year in
Bethesda, Maryland be included as part of the budget proposal.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) individual
research project grant (R01) award mechanism. Specific application
instructions have been modified to reflect "MODULAR GRANT" and "JUST-
IN-TIME" streamlining efforts being examined by the NIH. Complete and
detailed instructions and information on Modular Grant applications can
be found at http://grants.nih.gov/grants/funding/modular/modular.htm.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant. The total
project period for an application submitted in response to this RFA may
not exceed two years. Future unsolicited competing continuation
applications will compete with all investigator-initiated applications
and be reviewed according to the customary peer review procedures. The
anticipated award date is July 2002.
FUNDS AVAILABLE
The ORI intends to commit approximately $500,000 in FY 2002 grants in
response to this RFA. In addition to new applications, amended
applications for projects previously submitted to NIH will be accepted.
An applicant may request a project period of up to two years and a
budget for direct costs of up to $100,000 per year. Because the nature
and scope of the research proposed may vary, it is anticipated that the
size of each award will also vary. Although the financial plans of the
ORI provide support for this program, awards pursuant to this RFA are
contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to
clarify any issues or answer questions from potential applicants is
welcome.
Direct inquiries regarding programmatic issues to:
Mary D. Scheetz, Ph.D.
Office of Research Integrity
Division of Education & Integrity
5515 Security Lane, Suite 700
Rockville, MD 20852
(301) 443-5302
Email: Mscheetz@osophs.dhhs.gov
Mary Ellen Cheung, Ph.D.
NINDS/NIH
Neuroscience Center, Room 2209, MSC 9525
6001 Executive Boulevard
Bethesda, MD 20892-9525
(301) 496-1447
Email: mm108w@nih.gov
Karin Helmers, Ph.D.
Office of Extramural Programs
National Institute of Nursing Research
Building 45, Room Number 3AN12, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-2177
FAX: (301) 480-8260
Email: Karin helmers@nih.gov
Direct inquiries regarding review issues to:
Lillian M. Pubols, Ph.D.
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3208
Rockville, Maryland 208512
Telephone: (301) 496-9223
Email: lp28e@nih.gov
Direct inquiries regarding fiscal matters to:
Ms. Sheila Simmons
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3290
6001 Executive Boulevard
Bethesda, Maryland 20892-9231
Telephone: (301) 496-8084
Email: ss433y@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit by October 15, 2001, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to which
the application may be submitted. Although a letter of intent is not
required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows NINDS
staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent to:
Mary Ellen Cheung, Ph.D.
NINDS/NIH
Neuroscience Center, Room 2209, MSC 9525
6001 Executive Boulevard
Bethesda, MD 20892-9525
Rockville, MD 20852 (for courier service)
FAX: (301) 480-1080
Email: mm108w@nih.gov
SCHEDULE SUMMARY
Letter of Intent Receipt Date: October 15, 2001
Application Receipt Date: November 19, 2001
Peer Review Date: March 2002
Council Review: May 2002
Earliest Anticipated Start Date: July 2002
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants. These forms are available at most
institutional offices of sponsored research and from the Division of
Extramural Outreach and Information Resources, National Institutes of
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone 301/435-0714, email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
The modular grant concept establishes specific modules in which direct
costs may be requested as well as a maximum level for requested
budgets. Only limited budgetary information is required under this
approach. The just-in-time concept allows applicants to submit certain
information only when there is a possibility for an award. It is
anticipated that these changes will reduce the administrative burden
for the applicants, reviewers and Institute staff. The research grant
application form PHS 398 is to be used in applying for these grants,
with the modifications noted below.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000
modules, up to a total direct cost request of $100,000 per year. The
total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398
application instructions described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct
Costs (in $25,000 increments up to a maximum of $100,000) and Total
Costs [Modular Total Direct plus Facilities and Administrative (F&A)
costs] for the initial budget period. Items 8a and 8b should be
completed indicating the Direct and Total Costs for the entire proposed
period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form
Page 4 of the PHS 398. It is not required and will not be accepted with
the application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete
the categorical budget table on Form Page 5 of the PHS 398. It is not
required and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget
Narrative page. (See
http://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested
for each year. This is not a Form page.
o Under Personnel, list all project personnel, including their names,
percent of effort, and roles on the project. No individual salary
information should be provided. However, the applicant should use the
NIH appropriation language salary cap and the NIH policy for graduate
student compensation in developing the budget request.
For Consortium/Contractual costs, provide an estimate of total costs
(direct plus facilities and administrative) for each year, each rounded
to the nearest $1,000. List the individuals/organizations with whom
consortium or contractual arrangements have been made, the percent
effort of all personnel, and the role on the project. Indicate whether
the collaborating institution is foreign or domestic. The total cost
for a consortium/contractual arrangement is included in the overall
requested modular direct cost amount. Include the Letter of Intent to
establish a consortium.
Provide an additional narrative budget justification for any variation
in the number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information
used by reviewers in the assessment of each individual's
qualifications for a specific role in the proposed project, as well as
to evaluate the overall qualifications of the research team. A
biographical sketch is required for all key personnel, following the
instructions below. No more than three pages may be used for each
person. A sample biographical sketch may be viewed at:
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate
the type of agreement and the date. All appropriate exclusions must be
applied in the calculation of the F&A costs for the initial budget
period and all future budget years. (Note: Grants to unaffiliated
individuals are not eligible for facilities and administrative cost
reimbursement.)
o The applicant should provide the name and phone number of the
individual to contact concerning fiscal and administrative issues if
additional information is necessary following the initial review.
The RFA label available in the PHS 398 application form must be affixed
to the bottom of the face page of the application. Type the RFA number
on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review
committee in time for review. In addition, the RFA title and number
must be typed on line 2 of the face page of the application form and
the YES box must be marked.
There is a sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note
this is in pdf format.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed, photocopies, in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
Dr. Lillian Pubols
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3208
Rockville, Maryland 20852 (for express/courier service)
Applications must be received by the application receipt date listed in
the heading of this RFA. If an application is received after that
date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing
the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the ORI and NINDS staff. Incomplete and/or non-
responsive applications will be returned to the applicant without
further consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by NINDS in accordance with the review criteria
stated below. As part of the initial merit review, all applications
will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit,
generally the top half of the applications under review, will be
discussed, assigned a priority score, and receive a second level review
by the NINDS National Advisory Council and the NINR National Advisory
Council.
REVIEW CRITERIA
The goal of this grant program is to foster empirical research on the
institutions, processes, and values that positively and/or negatively
shape integrity in research. The sponsoring agencies are particularly
interested in studies that will inform policy making at DHHS, NIH, and
research institutions, with the goal of fostering appropriate attention
to integrity in their research programs. In the written comments
reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of this goal. Each of
these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application.
Note that the application does not need to be strong in all categories
to be judged likely to have major scientific impact and thus deserve a
meritorious priority score. For example, an investigator may propose
to carry out important work that by its nature is not innovative but is
essential to move a field forward.
(1) Significance: Does this study address an important problem? If the
aims of the application are achieved, how will the understanding of
research integrity be advanced? What will be the effect of these
studies on the concepts or methods that drive RRI and policy making
more broadly?
(2) Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Will the study result in significant
generalizable empirical information? Does the applicant acknowledge
potential problem areas and consider alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
(4) Investigator: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
(5) Environment: Does the scientific environment in which the work
will be done contribute to the probability of success? Do the proposed
investigations take advantage of unique features of the intellectual
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will
also be evaluated.
o The reasonableness of the proposed budget and duration in relation
to the proposed research.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the
project proposed in the application.
o The adequacy of the proposed plan to share data, if appropriate.
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities
o program balance among similarly meritorious applications.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups
and their sub-populations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification are provided
indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing research involving human subjects should
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research," published in the NIH Guide for
Grants and Contracts on August 2, 2000 (); a complete copy of the
updated Guidelines are available at . The revisions relate to NIH
defined Phase III clinical trials and require: a) all applications or
proposals and/or protocols to provide a description of plans to conduct
analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific and ethical reasons
not to include them. This policy applies to all initial (Type 1)
applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the Inclusion of Children as
Participants in Research Involving Human Subjects that was published in
the NIH Guide for Grants and Contracts, March 6, 1998, and is available
at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program
staff listed under INQUIRIES. Program staff may also provide
additional relevant information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained
within specified page limitations. Unless otherwise specified in an
NIH solicitation, internet addresses (URLs) should not be used to
provide information necessary to the review because reviewers are under
no obligation to view the Internet sites. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a
PHS-led national activity for setting priority areas. This Request for
Applications (RFA), "Research on Research Integrity", is related to one
or more of the priority areas. Potential applicants may obtain a copy
of "Healthy People 2010" at http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.853 and No. 93.361. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42
USC 241 and 284) and administered under NIH grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not
subject to the intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.